NCT05142306

A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults

A Phase 1, Open-Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) Administered Through Intramuscular, Subcutaneous or Intravenous Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 years of age with body mass index ≤35 kg/m\^2. Prior studies examined IV administration, and the secondary objective of the present study was to compare PK among the three administration routes. No placebo group was included in the phase 1 randomized design. The exploratory objective was to evaluate disease severity in participants that became positive for SARS-CoV-2.

Detailed description

Eligible participants were randomized in two cohorts to receive COVID-HIG by IM, SC or IV in a 1:1:1 ratio and were stratified based on baseline SARS-CoV-2 IgG antibody status (low seropositive/seronegative; high seropositives were excluded). Up to 36 participants were planned to be enrolled and dosed in the study. A protocol amendment truncated the study to 23 randomized participants due to the impact of high circulating SARS-CoV-2 omicron cases on enrollment and participant retention. Participants were planned to be followed through Day 85 (approximately three half-lives), but the protocol was amended to shorten the study length to Day 57 due to timeline and PK considerations. The third substantial protocol amendment change was to remove the planned pseudovirus neutralization assay from the study due to its low sensitivity, limiting the PK analysis to the S-protein binding IgG immunoassay. PK time points included predose and postdose (from end of infusion/injection) 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, Days 2, 3, 4, 6, 8, 15, 29, 43 and 57. Nasopharyngeal swabs for SARS-CoV-2 were collected throughout the study. Per protocol, participants who became SARS-CoV-2 positive could not be assessed for PK at time points after testing positive, as the assay could not distinguish COVID-HIG from native antibodies. Participants who became SARS-CoV-2 positive during the study had disease severity assessed using an Ordinal Outcome Scale and followed via telemedicine through the end of the study.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	COVID-HIG	Anti-SARS-CoV-2 Immunoglobulin (Human) \[COVID-HIG\] is a purified liquid immunoglobulin G (IgG) preparation

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-03-28
• Completion: 2022-05-31
• First posted: 2021-12-02
• Last updated: 2025-06-08
• Results posted: 2024-05-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study